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Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine if they are given Prevnar initially.
Patients will be randomized into either PCV13 and PPSV23 (Experimental) or PPSV23 alone (Active comparator). At the Week 0 time point, the patients will receive either PCV13 (Experimental) or PPSV23 (Active comparator) and undergo a blood draw of 5ml for assessment of pre-vacation serotype titers. The Active Comparator group will undergo a 5ml draw of blood for assessment of titers at week 8, 16, and 24 following vaccination. The Experimental group will undergo vaccination with PPSV23 at week 8 with 5 ml blood draw for pneumococcal serotype titers as well as a blood draw at week 16 and week 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCV13 and PPSV23 | Experimental | Participants randomized to receive PPSV23 primed with PCV13. Participants will receive PCV13 8 weeks prior to receiving PPSV23 |
|
| PPSV23 | Active Comparator | Participants randomized to receive PPSV23 alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCV13 | Biological | Single 0.5 ml dose of PCV13 administered via intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 | 5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL. | Baseline, week 0, week 8, week 16 |
| Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16 | 5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL. | Baseline, week 0, week 8, week 16 |
| Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16 | 5 ml blood draw for assessment of IgG specific Antibody titers for serotypes common PCV13 & PPSV23. Measured as mcg/mL. | Baseline, week 0, week 8, week 16 |
| Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16. | 5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL. | Baseline, week 0, week 8, week 16 |
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Inclusion Criteria:
- Diagnosis of asthma
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avni Y Joshi | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PCV13 and PPSV23 | Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23 PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously |
| FG001 | PPSV23 | Participants received PPSV23 alone PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PCV13 and PPSV23 | Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23 PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 | 5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL. | Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms. | Posted | Median | Inter-Quartile Range | mcg/dL | Baseline, week 0, week 8, week 16 |
|
Adverse Events were collected from baseline to end of study, approximately 16 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PCV13 and PPSV23 | Participants received PPSV23 primed with PCV13 PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Avni Y. Joshi, M.D., M.S. | Mayo Clinic | 507-284-3165 | Joshi.Avni@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2018 | Sep 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| PPSV23 | Biological | Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously |
|
|
| PPSV23 |
Participants received PPSV23 alone PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | PPSV23 | Participants received PPSV23 alone PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously |
|
|
| Primary | Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16 | 5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL. | Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms. | Posted | Median | Inter-Quartile Range | mcg/mL. | Baseline, week 0, week 8, week 16 |
|
|
|
| Primary | Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16 | 5 ml blood draw for assessment of IgG specific Antibody titers for serotypes common PCV13 & PPSV23. Measured as mcg/mL. | Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms. | Posted | Median | Inter-Quartile Range | mcg/mL | Baseline, week 0, week 8, week 16 |
|
|
|
| Primary | Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16. | 5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL. | Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms. | Posted | Median | Inter-Quartile Range | mcg/mL | Baseline, week 0, week 8, week 16 |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | PPSV23 | Participants received PPSV23 alone PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously | 0 | 9 | 0 | 9 | 0 | 9 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D045424 |
| Complex Mixtures |
| D017778 | Vaccines, Combined |
| week 8 |
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| week 16 |
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| week 8 |
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| week 16 |
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| week 8 |
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| week 16 |
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